Large and Small Volume Parenteral.pptx

preparation and stability Large and small
volume parental – physiological and formulation consideration,
Manufacturing and evaluation.

1. Large and Small Volume Parenteral By Gajanan Sormare

2. Contents- INTRODUCTION CLASSIFICATION OF PARENTERALS LARGE VOLUME PARENTERALS SMALL VOLUME PARENTERALS PREPARATION OF PARENTERALS FORMULATION CONSIDERATION

3. INTRODUCTION Parenteral means para enteron , beside the gut or beside the intestine A Parenteral dosage form can be defined as a sterile drug product, which is presented in the form of solution, suspension, emulsion, or reconstituted lyophilized powder, suitable for administration by injection into the body. Parenteral dosage forms differ from all other drug dosage forms, because they are injected directly into body tissue through the primary protective systems of the human body, the skin, and mucous membranes.

4. Ideal characteristics of parenterals Sterile Free from visible particulate matter Isotonic Chemically and physically stable Free from pyrogen Compatible

5. ROUTES OF ADMINISTRATION

6. ROUTES OF ADMINISTRATION Intradural- within the dural membrane surrounding the spinal cord Extradural- outside the dural membrane and within the spinal caudal canals Intracardiac (IC)- into the muscles of the heart Intraperitonial (IP)- into the peritonial cavity Intra-articular- into the synovial fuild (joints) Intra-mammary- into the mammary glands of breast

7. Routes of parenteral administration

8. CLASSIFICATION OF PARENTERALS It is classified into two: SMALL VOLUME PARENTERALS LARGE VOLUME PARENTERALS

9. Difference between svp and lvp -

10. LARGE VOLUME PARENTERALS

11. LARGE VOLUME PARENTERALS A single-dose injection that is intended for intravenous use. Packaged in glass bottles or in large volume flexible containers. May contain greater than 100 ml to greater than 1 or 2 L Sterile Pyrogen-Free Essentially free of particulate matter No anti-microbial agents Isotonicity

12. PRIMARY USES OF LVP: To provide nutrients when oral administration is not possible. To maintain acid base balance in the body. To act as a plasma expander. To provide water, electrolyte, and simple carbohydrates required for the body.

13. SMALL VOLUME PARENTERALS

14. SMALL VOLUME PARENTERALS Injected by a syringe. Less than 100 ml. Most routes are used. Could be made hypertonic. Could be pyrogenic.

15. PRIMARY USES OF SVP • Therapeutic injections • Ophthalmic products • Diagnostic agents • Allergenic extracts

16. FORMULATION OF PARENTERALS

17. FORMULATION OF PARENTERALS

18. ACTIVE DRUG: A thorough evaluation of properties of the active drug or drugs is essential in developing a stable and safe parenteral dosage form. VEHICLE: Aqueous vehicle Non aqueous vehicle

19. PRESERVATIVES: Required to prevent microorganism growth. Eg: Phenyl mercuric nitrate , thiomersal – 0.01% Benzethonium chloride, benzalkonium chloride – 0.5% Phenol, cresol – 0.5% BUFFERS: Add to maintain pH. Results in stability. Eg: citrate buffer, acetate buffer, phosphate buffer.

20. ANTIOXIDANTS: Protects from oxidation. Eg: Ascorbic acid (0.02 – 0.1%) Tocopherols (0.05 – 0.75%) TONICITY AGENTS: Reduce the pain at the injection site. Added at the last stage of production. Eg: Nacl, Kcl, Dextrose, Mannitol. SURFACTANTS: Used sometimes to enhance the solubility. Eg: sorbitan monooleate, polyoxy ethylene sorbitan monooleate.

21. CHELATING AGENTS: Used to bind in non- ionisable form, trace amount of heavy metals. Eg: Trisodium or calcium disodium salt of EDTA. INERT GASES: Used to displace oxygen from a solution and reduce possibility of oxidation. Eg: Nitrogen ( gentamycin sulfate injection) Carbon dioxide (sodium bicarbonate injection)